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IPT for Major Depression Following Perinatal Loss: Healing After Loss (HeAL)

IPT for Major Depression Following Perinatal Loss: Healing After Loss (HeAL)

Recruiting
18-50 years
Female
Phase 2/3

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Overview

This study tests the efficacy of interpersonal psychotherapy (IPT) for major depression following perinatal loss (early and late fetal death and early neonatal death) in a sample of 274 women in Flint and Detroit, Michigan. The trial will be the first fully powered randomized trial of treatment for any psychiatric disorder following perinatal loss.

Description

The goal of this study is to conduct a fully-powered randomized efficacy study of IPT for MDD following perinatal loss. Our perinatal-loss adapted group IPT will be compared to a standard depression intervention (CWD, also delivered in a group format) in a sample of 274 women experiencing MDD following perinatal loss. The proposed randomized controlled trial (RCT) will test the hypotheses that: (1) IPT for perinatal loss will result in reduced time to recovery from MDD (primary), depressive symptoms, and PTSD symptoms (secondary) relative to CWD; and that among women meeting criteria for PTSD, IPT will result in reduced time to recovery from PTSD; (2) IPT for perinatal loss will result in increased social support, social role functioning (including parental functioning for women with living children), and well-being, and decreased grief and fear of subsequent pregnancies, relative to CWD; and (3) social support and grief will mediate the effects of IPT on time to MDD recovery.

Eligibility

Inclusion Criteria:

  • women who meet current Diagnostic and Statistical Manual 5 (DSM-5) criteria for major depressive disorder (MDD)
  • have experienced a perinatal loss (including early and late fetal death, death of a liveborn neonate within the first 28 days, and medically recommended termination) within the last 1-12 months
  • are 18 to 50 years old
  • speak and understand English well enough to understand questionnaires when they are read aloud
  • can provide the name and contact information of at least two locator persons
  • have access to a telephone through owning one, a relative/friend, or an agency

Exclusion Criteria:

  • onset of current major depressive episode prior to news of difficulties with the pregnancy or health risk to the infant (women with prior episodes will be included)
  • current or past diagnosis of bipolar disorder, schizophrenia or other psychotic disorder
  • primary diagnosis of current substance use disorder
  • acute suicidal or homicidal risk
  • non-stable course of antidepressant medication or psychotherapy (i.e., beginning or changing dose of either within the previous 12 weeks)
  • any IPT or cognitive-behavioral treatment in the previous 12 weeks

Study details
    Major Depressive Disorder

NCT04629599

Michigan State University

14 October 2025

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